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A Post-marketing Surveillance to Assess Safety and Efficacy of Telostop Plus Tab.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03648801
Recruitment Status : Not yet recruiting
First Posted : August 27, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
IlDong Pharmaceutical Co Ltd

Tracking Information
First Submitted Date August 14, 2018
First Posted Date August 27, 2018
Last Update Posted Date August 31, 2018
Estimated Study Start Date September 2018
Estimated Primary Completion Date May 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 23, 2018)
  • Incidence of adverse event after this drug administration in general medical practice [ Time Frame: 24 weeks ]
    Any adverse events occurred after this drug dosing will be recorded. Description of adverse event(s) including type of adverse event(s), onset/end date, severity, action taken, causal relationship to the drug and investigator's view on the adverse event(s) will be captured, whether it is related to the drug or not and until follow up visit more than 1 time during the surveillance period. Lab abnormalities and changes in vital signs are considered to be adverse events only if they result in discontinuation from the study, necessitate therapeutic medical intervention, and/or if the investigator considers them to be adverse events.
  • Incidence of serious adverse event after this drug administration in general medical practice [ Time Frame: 24 weeks ]
    Any serious adverse events occurred after this drug dosing will be recorded. Description of serious adverse event(s) including type of serious adverse event(s), onset/end date, severity, action taken, causal relationship to the drug and investigator's view on the serious adverse event(s) will be captured, whether it is related to the drug or not and until follow up visit more than 1 time during the surveillance period. Lab abnormalities and changes in vital signs are considered to be serious adverse events only if they result in discontinuation from the study, necessitate therapeutic medical intervention, and/or if the investigator considers them to be serious adverse events.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Post-marketing Surveillance to Assess Safety and Efficacy of Telostop Plus Tab.
Official Title A Post-marketing Surveillance to Assess Safety and Efficacy of Telostop Plus Tab.
Brief Summary Post-marketing surveillance of Telostop Plus Tab.
Detailed Description This study will collect clinical data, mainly focused on safety, in Korean population as per the requirement of MFDS for market authorization.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The patient diagnosed with hypertention and dyslipidemia
Condition Hypertension, Dyslipidemia
Intervention Not Provided
Study Groups/Cohorts Hypertention, Dyslipidemia
NA (Observation study)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: August 23, 2018)
600
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2024
Estimated Primary Completion Date May 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • The patient who is first prescribed and administered Telostop plus Tab.

Exclusion Criteria:

  • The patients who are overreacting to this drug or its components
  • The patients with severe renal impairment
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Not Provided
Contacts
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03648801
Other Study ID Numbers ID-TAR-P401
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party IlDong Pharmaceutical Co Ltd
Study Sponsor IlDong Pharmaceutical Co Ltd
Collaborators Not Provided
Investigators Not Provided
PRS Account IlDong Pharmaceutical Co Ltd
Verification Date August 2018